Introduction: Deep Brain Stimulation (DBS) systems have traditionally used ring-shaped electrodes that produce a spherical stimulation field, thereby limiting the extent of volume of tissue activated. A pilot study of 7 PD subjects reported that a novel, directional permanently implanted DBS system, combining an eight-contact directional lead and an implantable pulse generator (IPG) capable of multiple independent current control (MICC), can accomplish directional current steering (Steigerwald F. et al., Mov Disord, 2016). This study evaluates clinical outcomes in subjects implanted with a directional lead for use in managing motor symptoms of levodopa-responsive Parkinson’s disease (PD) as part of an on-going registry.
Methods: The is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. Patients are implanted with a a CE-marked, MICC-based DBS system (Vercise, Boston Scientific) with a non-rechargeable battery. Subjects will be followed up out to 3 years post-implantation. Clinical endpoints will be evaluated at baseline and during study follow up that include Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change. Adverse events are also collected. Subjects in this specific cohort were implanted with a directional lead included as part of a directional DBS system (Vercise Cartesia, Boston Scientific) for bilateral STN-DBS.
Results: Preliminary data suggests an overall improvement in Quality of life at 6 months post implant as compared with Baseline as measured by a 17.6% (n = 89) improvement in PDQ-39 Summary Index. Over 90% of patients, caregivers and clinicians reported improvement as compared with Baseline. This report will provide the safety and effectiveness outcomes of the first cohort of subjects analyzed at 6 (N=150) and 12 months (N=100) post-implantation as compared with baseline.
Conclusions: Data from this specific cohort will provide insight on the use of current steering with a directional lead, and its implications in the treatment of patients.
Patient Care: Using directional stimulation, it may be possible to achieve a bigger therapeutic window, thereby facilitating enhanced programming flexibility when optimizing for efficacy, while decreasing the likelihood of surpassing the adverse effect threshold.
Learning Objectives: By the conclusion of this session, participants should be able to:
1) evaluate preliminary clinical outcomes in subjects implanted with a directional Lead
2) obtain insight regarding the potential advantage(s) of current steering using a directional lead as part of a directional DBS system
References: Steigerwald F. et al. Mov Disord. 2016 Aug;31(8):1240-3.